Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01472731 | Safety and Imaging Study of GC1008 in Glioma | PHASE2 | COMPLETED | 12 | — | — | Dec 1, 2011 | Nov 1, 2012 | May 6, 2024 | 1 | Netherlands |
Part 1, Biomarker imaging: 89Zr-GC1008 PET imaging in patients with suspicion of a malignant glioma: Primary endpoint: \- Quantification of uptake of 89Zr-GC1008 as determined by PET imaging. The data obtained from the PET-scans will be quantified as standardized uptake value (SUV).
Part 2, In relapsed malignant glioma patients 89Zr-GC1008 PET imaging followed by participation in phase 2 study of GC1008 Primary endpoint: \- Quantification of uptake of 89Zr-GC1008 in relapsed malignant glioma patients as determined by PET imaging. The data obtained from the PET-scans will be quantified as standardized uptake value (SUV).
| Arm | Type | Description |
|---|---|---|
| GC1008 imaging and treatment | EXPERIMENTAL | Part 1: Feasibility of 89Zr-GC1008 PET imaging in patients with suspicion of a malignant glioma to assess if GC1008 penetrates into the brain tumor and to quantify its uptake. Part 2: 89Zr-GC1008 PET imaging in patients with relapsed malignant glioma and phase II extension study with therapeutic GC1008 in these patients |
| Name | Type | Description |
|---|---|---|
| 89Zr-GC1008 | OTHER | radioactive labeled GC1008, intravenous use, 37 MBq total |
| GC1008 | DRUG | 5 mg/kg intravenous use |
Part 1 Inclusion Criteria * \> 18 years * WHO 0,1,2 * Suspicion of malignant glioma on contrast-enhanced MRI * Able to give written informed consent Exclusion Criteria * Meningeal carcinomatosis, uncontrolled seizures, or a disease that either causes or threatens neurologic compromise * Pregnant...